A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01119859|
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : February 11, 2013
Last Update Posted : February 11, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Tocilizumab Drug: Adalimumab Drug: Placebo to tocilizumab Drug: Placebo to adalimumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Drug: Placebo to adalimumab
Active Comparator: Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Drug: Placebo to tocilizumab
- Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) [ Time Frame: Baseline to Week 24 ]The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
- Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 [ Time Frame: Week 24 ]The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
- Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 [ Time Frame: Week 24 ]The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
- Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
- Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 [ Time Frame: Baseline to Week 24 ]Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
- Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 [ Time Frame: Baseline to Week 24 ]Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult patients, ≥ 18 years of age.
- Rheumatoid arthritis of > 6 months duration.
- Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
- All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
- Weight ≤ 150 kg.
- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
- History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- Treatment with a biologic agent at any time prior to baseline.
- Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119859
|Study Director:||Clinical Trials||Hoffmann-La Roche|
|Responsible Party:||Hoffmann-La Roche|
|Other Study ID Numbers:||
|First Posted:||May 10, 2010 Key Record Dates|
|Results First Posted:||February 11, 2013|
|Last Update Posted:||February 11, 2013|
|Last Verified:||January 2013|
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